Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026637
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2001-11-14
Brief Title:
Depression and Health Outcomes in Refractory Epilepsy
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Depression and Health Outcomes in Refractory Epilepsy
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To define the benefits of antidepressant treatment or cognitive behavior therapy on mood function and quality of life in persons with depression and refractory epilepsy
Detailed Description:
This randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression antiepileptic medication compliance seizure frequency and quality of life outcomes in persons with depression and a seizure disorder or epilepsy Approximately 140 persons will be enrolled in this study over a period of five years Individual participation will last approximately 16 weeks Study participants will be chosen randomly to receive either the study medication sertraline or cognitive behavior therapy for 16 weeks Sertraline is approved by the Food and Drug Administration FDA Subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks All study participants will attend scheduled clinic visits every 4 weeks for 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01NS040808-04 | NIH | None | httpsreporternihgovquickSearch5R01NS040808-04 |